资源描述：
《brazil the system for the protection of voluntary participants in research》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。
1、Chapter6Brazil:TheSystemfortheProtectionofVoluntaryParticipantsinResearchCorinaBontempoDucadeFreitas,WilliamSaadHossne,andSusieDutra6.1FirstStepsinResearchInvolvingHumansDiscussionsontheestablishmentofethicalparametersandtheregulationofclinicaltrialswithhumanparticipantsbeganinEuropeandtheUnitedSt
2、atesinthe1950s,gainingincreasingemphasisduringthe1970sand1980s.InBrazil,clinicalresearchgrewduringthe1980s,wheninvestigatorsfromEuropeandtheUSAinvitedmajorBraziliancenterspublichospitalsandacademiccenterstotakepartinclinicaltrials.Asaresult,thefirstcentersforresearchwereestablished,and,asinotherpar
3、tsoftheworld,someincidentshappenedwhichcausedconcernandillustratedtheneedforregulationstoprotectstudysubjects.TheNorplantstudywasamajorcaseinpoint.Norplant,along-term(fiveyears)contraceptive,developedbythePopulationCounciloftheUnitedStates,consistsofsixcapsulesoflevonorgestrelinsertedbeneaththeskin
4、(IsraelandDacach1993).NorplantbegantobeusedinBrazilinthemid-1970s,butwasnotreviewedbythehealthauthoritiesuntil1984.Atthattimethecountryhadamilitarygovernment,manyuniversitieshadlinkswithpopulationcenters,andethicalstandardswerelowered.Forexample,whentheUniversityofCampinaspresentedtheNorplantproje
5、cttothehealthauthoritiesin1984,thePresidentoftheUniversitywasamemberoftheadvisorycommitteeofthePopulationCouncil,andthestudywasapprovedwithoutfulfillingfundamentalethicalstandards.Thestudydidnotrequirewomentogiveinformedconsent,theC.B.D.deFreitas(*)Coordenac¸aodePesquisaeComunicac¸aoCientı´fica,Fund
6、ac¸aodeEnsinoePesquisaemCienciasdaSau´deFEPECS,Brasilia,Brazile-mail:corinabdf@gmail.comW.S.HossneBIOE´TICA,CentroUniversitarioSaoCamilo,SaoPaulo,BrazilS.DutraComitedeE´ticaemPesquisa,Fundac¸aoHemominas,BeloHorizonte,BrazilN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics131andBu
7、sinessClash,ResearchEthicsForum2,DOI10.1007/978-3-319-01363-3_6,©SpringerInternationalPublishingSwitzerland2014132C.B.D.deFreitasetal.useoftheproductwasillegallypromotedinthemassmedia,thenumberofrecruitmentcenter
